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ISO 9001 : 2000. Objective Introduce the concept of ISO 9001 Standard Highlight important areas of ISO 9001 Standard Briefly introduce the system requirements.

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Presentation on theme: "ISO 9001 : 2000. Objective Introduce the concept of ISO 9001 Standard Highlight important areas of ISO 9001 Standard Briefly introduce the system requirements."— Presentation transcript:

1 ISO 9001 : 2000

2 Objective Introduce the concept of ISO 9001 Standard Highlight important areas of ISO 9001 Standard Briefly introduce the system requirements of ISO 9001 Standard

3 What is ISO 9001: 2000 Quality Management System Requirement Standard from International Organization for Standards Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994 Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements

4 ISO 9001:2000 ISO 9001:2000 QMS Resource management Measurement, analysis & improvements Product Realization Management Responsibility Continual Improvement cycle General requirements

5 ISO 9001 : 2000 – Model CUSTOMERS Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8. Measurement Analysis and Improvement Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product

6 Principles of ISO 9001:2000 Based on eight quality management principles Leadership Process approach Involvement of people System approach to Managemen t Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus

7 Principles of ISO 9001:2000 Customer focus Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations Leadership Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organization’s objectives Involvement of People People of all levels are essence of an organization Their full involvement for organization’s benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process

8 Principles of ISO 9001:2000 System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency Continual improvements Continual improvement of the organization’s overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships An organization & its suppliers are interdependent Mutually beneficial relationship enhances the ability of both to create value

9 Expectations of ISO 9001:2000 Avoid the application of systems that are separate from the organization’s business process Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business Enable Continual improvements of the system for enhanced customer satisfaction Enable compliance to statutory & regulatory requirements

10 Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs Process definition Set of interrelated or interacting activities which transforms inputs into outputs Ensure continual improvements Identify the processes Do it for all value adding processes Establish measurin g criteria Identify the Interactions to other processes Identify the Inputs & outputs

11 Process approach – Continual improvements of Process PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK Understandings & meeting requirements PLAN

12 E.g. - Purchasing Process Performance Measurements Delivery status – On-time, On spec, NCP etc Supplier evaluation Performance Measurements Delivery status – On-time, On spec, NCP etc Supplier evaluation Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time Purchasing Procedure Purchasing Procedure Interactions to Storage Inspection and Testing Manufacturing Finance Interactions to Storage Inspection and Testing Manufacturing Finance Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements

13 Provision of resources Human resources Infrastructures Work environment 6 Resource Management General requirements Documentation Requirements Planning Customer related processes Design & development Purchasing Production & service provision Management Commitment Customer focus Quality policy Planning Responsibility, authority & communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & improvement System Requirements / Structure of the Standard 4 Quality Management System 7 Product Realization General Monitoring & measurement Control of NCP Analysis of data Improvements

14 4 - Quality management system 4.1 General requirements 4.1 General requirements Identification of processes required Identification of processes required Criteria and methods to ensure Operation & control Criteria and methods to ensure Operation & control Availability of information & resources for operation & control Availability of information & resources for operation & control Monitoring and Measuring of processes Monitoring and Measuring of processes Continual improvements Continual improvements

15 4 - Quality management system Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records 4.2 Document requirements

16 5.5 Responsibility authority & communicate 5.4 Planning 5 - Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.6 Management Review 5.3 Quality policy Quality objectives QMS planning General Review inputs Review outputs Internal communication Management representative Responsibility & authority

17 5 - Management Responsibility Development, implementation and continually improvement of QMS Communication of importance of Regulatory & statutory requirements Meeting customer requirements Quality Policy & Quality objectives Responsibilities & authorities Communication of importance of Regulatory & statutory requirements Meeting customer requirements Quality Policy & Quality objectives Responsibilities & authorities Appointment of Management Representative Conducting Management Reviews Providing required resources Appointment of Management Representative Conducting Management Reviews Providing required resources Establishment of Quality Policy Quality Objectives Establishment of Quality Policy Quality Objectives Identification of Customer requirements Top Management’s commitment

18 5 - Management Responsibility Evidence must be provided to show that the Management is committed to the above requirements Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system

19 6.4 Work Environment 6.3 Infrastructures 6 - Resource Management 6.2 Human Resources General Competence, awareness & training 6.1 Provision of resources

20 6 - Resource Management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Human Resources Infrastructures Infrastructures needed to achieve product conformity Infrastructures Infrastructures needed to achieve product conformity Work environment Work environment needed to achieve product conformity Work environment Work environment needed to achieve product conformity Resource Managemen t

21 6 - Human Resources Enhanced Competent on the basis of appropriate education, skill and experience Define competencies for people performing work affecting product quality Provide training or actions Evaluate effectiveness of the training / actions Employees should aware importance of the activity being performed 6.2 Human Resources

22 7.6 Control of monitoring measuring devices Control Preservation of product Validation of processes Identification & traceability Customer property 7.5 Production & service provision Verification of purchased products Purchasing process Purchasing information 7.4 Purchasing Design planning Design inputs Design outputs Design review Design Changes Design validation Design verification 7.3 Design and development 7 - Product Realization 7.1 Planning of product realization Identification of customer requirement Review of customer requirement Customer communication 7.2 Customer related processes

23 7 - Product Realization Quality objectives of Products – Specs Processes, procedures to realize product Verification, validation, monitoring, inspection and testing of product Record to demonstrate conformance 7.1 Planning of Product realization 7.1 Planning of Product realization

24 7 - Product Realization Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements Effective communication with customer in relation to Product information Sales order handling Customer feedback Customer complaints Effective communication with customer in relation to Product information Sales order handling Customer feedback Customer complaints Identification of Customer / Market requirements Specified by customer Requirements taken for granted Statutory / Regulatory requirements Identification of Customer / Market requirements Specified by customer Requirements taken for granted Statutory / Regulatory requirements 7.2 Customer related processes – (Sales) 7.2 Customer related processes – (Sales)

25 7 - Product Realization Design inputs and outputs Review and verification, validation and control of changes Accuracy Potential hazards & faults Corrections Evaluations against lessons learned Review and verification, validation and control of changes Accuracy Potential hazards & faults Corrections Evaluations against lessons learned Planning Effective & efficient Expectations of interested parties EHS Planning Effective & efficient Expectations of interested parties EHS 7.3 Design and Development – (Product) 7.3 Design and Development – (Product)

26 Clause 7.3 Design Process Design plan 7.3.1 Design Review 7.3.4 Design validation 7.3.6 Design Input 7.3.2 Design changes 7.3.7 Design Process Design verification 7.3.5 CUSTOMERCUSTOMER Design Output 7.3.3 USERSUSERS

27 7 - Product Realization Supplier evaluation Verification of purchased product – Inspection and testing Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements

28 7 - Product Realization Product characteristics (Specs) Procedures and work instructions Suitable equipments to manufacture. Monitoring and inspection & testing Product release, delivery and post delivery Process validation Identification and traceability Customers property Material supplied by customers – e.g.. 3 rd party blending Customers property Material supplied by customers – e.g.. 3 rd party blending 7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product 7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product

29 7 - Product Realization 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing

30 8 - Measurement, analysis and improvement 8.2 Monitoring & measurements 8.4 Analysis of data 8.5 Improvement 8.3 Control of non conforming product Measurement of product Internal audits Customer satisfaction Measurement of processes Corrective action Preventive action Continual improvements 8.1 General

31 8 - Measurement, analysis and improvement To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system 8.2 - Monitoring and Measurements Customer satisfaction / perception Internal audits - conformity planned arrangements of QMS and ISO9001 Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results Monitoring and measurements of product – Conformity to product requirements 8.2 - Monitoring and Measurements Customer satisfaction / perception Internal audits - conformity planned arrangements of QMS and ISO9001 Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results Monitoring and measurements of product – Conformity to product requirements 8.3 - Control of NCP T o assure that NCP products are identified and controlled to prevent unintended use / delivery 8.3 - Control of NCP T o assure that NCP products are identified and controlled to prevent unintended use / delivery 8.1 - To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system 8.1 - To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system

32 8 - Measurement, analysis and improvement 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system Analysis shall provide information related to Customer satisfaction / perception Conformity to specs, requirements Trends of processes and products Opportunities for preventive actions Suppliers

33 8 - Measurement, analysis and improvement 8.5 - Improvements Continual Improvements QMS needed to be continually improved 8.5 - Improvements Continual Improvements QMS needed to be continually improved Corrective action Actions to prevent recurrence of NCP, NCR etc Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records Corrective action Actions to prevent recurrence of NCP, NCR etc Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records Preventive action Actions against potential non conformities to avoid their occurrence Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records Preventive action Actions against potential non conformities to avoid their occurrence Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records

34 Criteria for measurements –Internal audits Effectiveness & efficiency of processes Opportunities for improvements Use of data / information Effective & efficient use of resources Adequacy, accuracy and performance of measurements Relationships with customers/ suppliers/ other interested parties –Internal audits Effectiveness & efficiency of processes Opportunities for improvements Use of data / information Effective & efficient use of resources Adequacy, accuracy and performance of measurements Relationships with customers/ suppliers/ other interested parties –Financial measurements Prevention cost Non conforming / failure cost Lifecycle cost –Financial measurements Prevention cost Non conforming / failure cost Lifecycle cost Self assessment –Satisfaction surveys for customers and other interested parties Feedback on products Customer & market requirements –Satisfaction surveys for customers and other interested parties Feedback on products Customer & market requirements System performanc e

35 Criteria for measurements –Inspection and testing of incoming, in process and final product –Product verification –Product validation –Inspection and testing of incoming, in process and final product –Product verification –Product validation –Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction –Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction Products Processes

36 Pros and Cons More business oriented. Less procedure oriented Company wide involvement Mutual benefit to all interested parties Customer focus than product focus More resource demanding ?? Continual improvements Less emphasis on documentation

37 Challenges in implementing ISO 9001:2000 Communication Management Support Other employee Support ISO 9001:2000 Encouragement

38 Thank You


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